MAUDE Adverse Event Report: NUVASIVE INC. ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Model Number 1558700

Device Problems Malposition of Device (2616); Appropriate Term/Code Not Available (3191)

Patient Problems Abscess (1690); Bacterial Infection (1735); Laceration(s) (1946); Septic Shock (2068); Blood Loss (2597)

Event Type  Death  

Manufacturer Narrative

No product has been returned for investigation as no product malfunction was alleged.No indication of nuvasive's product causing or contributed to event.No root cause can be identified at this time.

Event Description

During literature review it was identified patient underwent an extreme lateral interbody fusion procedure via a right-sided lateral transpsoas approach to treat an l4-5 levels.As per reporter upon attempts to retract the detachable retractor blade, the surgeon encountered bleeding.The patient was transferred to the hospital for an emergency procedure.It was discovered that the patient experienced vascular injuries.During the emergency procedure, the patient was hypotensive, had an estimated blood loss of 9200ml, and underwent bilateral lower-extremity full compartment fasciotomies and was transferred to icu in critical condition.The following 4 weeks, the patient underwent 5 additional surgical procedure.Within the next few days, the patient expired due to multiple organ failure secondary to septic shock.

Manufacturer Narrative

No product malfunction was alleged or identified.No radiographs or lab reports provided so the complaint was not confirmed.Review of the reported event identified that post-retractor usage the patient experienced multiple vascular injuries which suggests improper placement and or excessive retraction as a possible cause.The patients injuries required five additional procedures over the following weeks after which retroperitoneal abscess and bacteremia were identified and treated but followed by septic shock and organ failure.All considered contributors to the subsequent death.Nuvasive instrumentation is processed and sterilized by the end user facility and sterilization records were not provided.Labeling review: ".Contraindications contraindications include, but are not limited to infection, local to the operative site.Signs of local inflammation.Patients with physical or medical conditions that would prohibit beneficial surgical outcome." ".Potential adverse events and complications as with any major surgical procedures, there are risks involved in orthopedic surgery.Infrequent operative and postoperative complications that may result in the need for additional surgeries include.Early or late infection.Damage to blood vessels, spinal cord or peripheral nerves.Pulmonary emboli.Loss of sensory and/or motor function.Impotence and permanent pain and/or deformity.Rarely, some complications may be fatal." ".Warnings, cautions and precautions the anterior retractors do not rigidly attach to the access driver/retractor body through use of the anterior crossbar.Use caution when impacting with these instruments in place." ".Pre-operative warnings the method of use for the instruments are to be determined by the user¿s experience and training in surgical procedures.Do not use these instruments for any action for which it was not intended such as hammering, prying or lifting.The instruments should be treated as any precision instrument and should be carefully placed on trays, cleaned after each use, and stored, according to generally accepted hospital methods and practices.The instruments should be carefully examined prior to use for functionality, excessive wear or damage.A damaged instrument should not be used as this may increase the risk of malfunction and potential patient injury.Instruments should be protected during storage and from corrosive environments.Refer to cleaning and sterilization instructions below for all non-sterile parts.Care should be used during surgical procedures to prevent damage to the device and injury to the patient." ".Intra-operative warnings the physician should take precautions against putting undue stress on the spinal area with instruments.Any surgical technique should be carefully followed.It is important that the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels, and that the force applied to the instrumentation is not excessive, to prevent potential injury to the patient." ".Cleaning and decontamination all non-sterile instruments must first be thoroughly cleaned using the validated methods prescribed in the nuvasive cleaning and sterilization instructions doc 9400896 before sterilization and introduction into a sterile surgical field.Contaminated instruments should be wiped clean of visible soil at the point of use, prior to transfer to a central processing unit for cleaning and sterilization.The validated cleaning methods include both manual and automated cleaning.Visually inspect the instruments following performance of the cleaning instructions to ensure there is no visual contamination of the instruments prior to proceeding with sterilization.If possible contamination is present at visual inspection, repeat the cleaning steps.Contaminated instruments should not be used, and should be returned to nuvasive.Contact your local representative or nuvasive directly for any additional information related to cleaning of nuvasive surgical instruments.Instruments with a d prefix part number may be disassembled.Please refer to the additional disassembly instructions for these instruments." ".Sterilization all non-sterile instruments are sterilizable by steam autoclave using standard hospital practices, in addition to nuvasive¿ s validated parameters.In a properly functioning and calibrated steam sterilizer, effective sterilization may be achieved using the parameters prescribed in the nuvasive cleaning and sterilization instructions.".

Event Description

See h10 for list of corrected information.

• Brand Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Type of Device: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): NUVASIVE INC.; 7475 lusk blvd; san diego CA 92121
• MDR Report Key: 10099807
• MDR Text Key: 193293825
• Report Number: 2031966-2020-00103
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• PMA/PMN Number: K170962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1558700
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Death; Hospitalization; Other
• Patient Age: 50 YR